Notification of a change in sponsorship

19 August 2016

Changes to the sponsorship of therapeutic goods in an entry in the ARTG occur where:

  • the sponsor dies, is made bankrupt, or (if they are a company) the business is wound up, or
  • the sponsor transfers or assigns the registration, listing or inclusion of the goods in the Register to the person to whom the business or interest is transferred or assigned (the new sponsor).

As a result of such events, the new sponsor becomes responsible for the therapeutic goods in the ARTG entry, and must notify us of that event.

You as a sponsor are also required to notify us if you change your name, or amalgamates with another company under another name.

For more information, see: Changing the sponsor of therapeutic goods

Change of sponsorship after death, bankruptcy, or winding up

How to access a pdf or Word document

These forms are available in pdf and Microsoft Word formats. The pdf forms can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

For more details, see: Change of sponsorship after death, bankruptcy or winding up

Change in business or product ownership

For more details, see: Change in business or product ownership

Change of sponsor name

You also need to tell us where you as a sponsor (whether an individual or a company):

  • change your name, or
  • if a company, you amalgamate with another company (and as a result change your name).

This does not result in a change of sponsor, but it does require us to update any relevant ARTG entries to ensure they remain accurate. You need to do this within 3 months of changing your name. If 3 months has passed, please notify us as soon as possible.

How do I notify the TGA?

Please use the following form to notify the TGA:

When you complete the form, ensure that you:

  • make the relevant declarations about the change of name, including the date on which it occurred.

Who signs the forms?

The person to sign the forms must be either:

  • the sponsor; or
  • a person who has the authority of the sponsor to sign the form (e.g. a partner of a law or accountancy firm, or a person authorised to sign the form on that person's behalf).

If the ABN or ACN is also changing

If changing the business name involves changing the Australian Business Number (ABN) or Australian Company Number (ACN), this constitutes forming a new business entity and therefore a change of sponsorship.

This is considered to be a transfer of business, and therefore needs to follow the process for a Change in business ownership.

Relevant legislation

The Therapeutic Goods Regulations 1990 provides the basis for change of name:

  • Listed and registered therapeutic goods - regulation 10AC (change of name)
  • Medical devices - regulation 10FA (change of name)
  • Biologicals - regulation 10HA (change of name).